A Phase II Trial of Intermediate Radiation Dose For Lymphoma
The purpose of this study is to determine the optimal radiation dose fractionation regimen for low grade follicular lymphoma.
It is hypothesized that the complete response rate with the use of 12 Gy in 6 daily fractions is 80% (10% total width of the confidence interval) at 3 months.
This phase II study will evaluate whether an intermediate dose for follicular lymphoma is associated with excellent response rates while minimizing acute and late toxicity.
|Condition or Disease||Intervention/Treatment||Phase|
Arms and Interventions
|Experimental: 12 Gy in 6 daily fractions
Radiation: 12 Gy in 6 daily fractions
12 Gy in 6 daily fractions
Primary Outcome Measures
- Complete response within the radiated volume at 1month post radiation [1 month]
Participants will be assessed for response at 1 month (primary outcome) and then 3 months following completion of radiotherapy, clinically or radiographically, as appropriate. Complete response is defined as absence of detectable disease in the radiated volume. Partial response is 50% or more reduction in the volume of disease in the radiated volume. Overall response is defined as complete and partial response. Stable disease is defined as no change in the irradiated tumour or less than 50% reduction. Progressive disease is defined as enlargement of the irradiated tumour
Secondary Outcome Measures
- Overall survival, progression-free survival and toxicity [1 month and 3 month]
Toxicity (6) will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) definitions (site specific modules), at 1 month and then 3 months following completion of radiotherapy.
≥ 18 years or older
Pathology review at Sunnybrook Health Sciences Centre showing low grade (grade 1- 2) follicular lymphoma
Previously un-irradiated stages I-IV low grade follicular lymphoma
Radiation indicated for local disease control (radical or palliative)
Able to give informed consent
Non-bulky targets (less than 7cm)
Systemic therapy (including steroids) for lymphoma within 3 months before or after radiotherapy
Prognosis less than 3 months
Contacts and Locations
|1||Sunnybrook Health Sciences Centre||Toronto||Ontario||Canada||M4N 3M5|
Sponsors and Collaborators
- Sunnybrook Health Sciences Centre
- Principal Investigator: May Tsao, MD, Sunnybrook Health Sciences Centre
Study Documents (Full-Text)None provided.